NCT06971055

Brief Summary

This randomized clinical trial aims to evaluate and compare the antimicrobial efficacy of Moringa Oleifera leaf extract versus sodium hypochlorite as root canal irrigants in pulpectomy of nonvital primary molars in pediatric patients. The study will assess bacterial reduction using blood agar

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 2, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

Moringa oleiferaSodium hypochloriteRoot canal irrigantsPulpectomyPrimary molarsEnterococcus faecalisAntimicrobial efficacyPediatric endodonticsCoagulase-Negative Staphylococci

Outcome Measures

Primary Outcomes (1)

  • Zone of inhibition against Coagulase-Negative Staphylococci

    "Primary Outcome: The antimicrobial efficacy of both types of irrigants... based on the diameter of the zone of inhibition

    "Day 1 (Pre- and post-irrigation samples collected during the same visit)"

Study Arms (2)

Sodium Hypochlorite Group

EXPERIMENTAL

Participants in this group will receive root canal irrigation using sodium hypochlorite during pulpectomy of nonvital primary molars. A 3 mL solution will be used per canal following standard clinical procedures.

Drug: Sodium hypochlorite

Moringa oleifera Leaf Extract Group

EXPERIMENTAL

extract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant.

Biological: Moringa Oleifera Leaf Extract

Interventions

sodium hypochlorite solution will be used as a root canal irrigant during pulpectomy in primary molars. A volume of 3 mL will be delivered into each canal using a syringe with a side-vented needle. Irrigation will be followed by microbial sampling for blood agar

Sodium Hypochlorite Group

extract of Moringa oleifera leaves will be used as an intracanal irrigant during pulpectomy. A volume of 3 mL will be used per canal, and post-irrigation microbial samples will be analyzed using the same methods as the control group.

Moringa oleifera Leaf Extract Group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4 to 7 years
  • Clinically and radiographically diagnosed with nonvital primary molars requiring pulpectomy
  • Cooperative children who can undergo dental treatment
  • Healthy-appearing children with no systemic, physical, or mental disorders

You may not qualify if:

  • Medically compromised or uncooperative children
  • Primary molars indicated for extraction due to:
  • Advanced root resorption (more than two-thirds)
  • Teeth near exfoliation
  • Deep subgingival caries preventing proper restoration
  • Excessive mobility (Miller's Grade 2 or higher)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental CariesDental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Pulp DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Central Study Contacts

Alawi Taha Alaidarous T Principal Investigator, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 14, 2025

Study Start

July 20, 2025

Primary Completion

September 15, 2025

Study Completion

January 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations